Kornimate/medical-research-clean huggingface dataset:
safety registry of a fecal microbiota transplant cohort

Conditions: Clostridium Difficile Infections

Summary: clostridium difficile infection (cdi) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. recurrent forms are a major problem with this infection. the use of fecal microbiota transplantation (fmt), fmt appears in the most recent european and north american recommendations. there is no cohort or multicenter registry in france prospectively collecting fmts, the methods used, their efficacy and side effects. likewise, there is no prospective collection focused on the cohort of stool donors. a large national cohort of patients who have undergone fmt as part of routine care as well as donors, is essential for evaluating the safety of fmt.

clostridium difficile infection (cdi) is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea. for 20 years, the incidence of cdi has continued to increase. in addition, the severity of infections is also increasing (mortality: 5% in 1990 against 13.8% in 2003; complications: 6% in 1990 against 18% in 2003). recurrent forms represent a major problem of this infection. indeed, after a first episode, the risk of a first recurrence is around 15 to 25% and this risk then increases with each recurrence, reaching 45% then 65% after a first and second recurrence respectively. these recurrent forms pose a real therapeutic problem, causing significant morbidity (repeated hospitalizations, time off work, etc.) and substantial mortality. patients with cdi are 2.5 times more likely to die within 30 days of infection than uninfected patients, regardless of age or comorbidities. the mortality rate is also higher in patients with a recurrent form than in those with a single episode. furthermore, the antibiotics usually used are only marginally effective in cases of recurrent cdi. numerous studies, including two randomized trials, have shown that fecal microbiota transplantation (fmt), is superior to antibiotic therapy in reducing subsequent recurrences, the use of fmt in this indication appears in the most recent european and north american recommendations. cosmic-fmt cohort aims to be as representative as possible of the population of patients having fmt for cdi in the context of care.

Eligibility criteria:
inclusion criteria: patients : * adult patient with an indication for fmt for cdi (severe refractory cdi, recurrent cdi); * informed written consent donors: * adult (18 years or older) * informed written consent exclusion criteria: * insufficient level of understanding of written and spoken french language

Keywords: clostridium difficile infection fecal microbiota transplantation
resuscitation outcomes consortium (roc) prehospital resuscitation using an impedance valve

Conditions: Heart Arrest

Summary: the purpose of this study is to look at two different treatments during a cardiac arrest that occurs outside of the hospital and whether either or both treatments will increase the number of people who live to hospital discharge. a cardiac arrest is when the heart stops pumping blood to the body.

the first treatment involves using a device called the impedance threshold device (itd). the itd is a small hard plastic device about the size of a fist that is attached to the face mask or airway tube used during cpr (cardiopulmonary resuscitation). the itd provides increased blood flow back to the heart during chest compressions until the heart starts beating on its own again. the other treatment involves the amount of cpr given before the emergency medical services (ems) providers first look at the heart rhythm to determine if a shock is needed. a person would receive either about 30 seconds of chest compressions or about 3 minutes of compressions before checking the heart rhythm. giving some compressions before checking the heart rhythm increases the blood being circulated to the body. researchers do not know how many compressions before the rhythm check are necessary to save more lives. depending on the circumstances of the cardiac arrest a person may receive only one of these treatments or both of these treatments. the purpose of the research study is to determine if more people live when either the real itd is used or if additional cpr is given before looking at the heart rhythm the first time. this study is being conducted in 9 different areas throughout the united states and canada by the resuscitation outcomes consortium (roc). about 15,000 patients will be enrolled in this research study.

Eligibility criteria:
inclusion criteria: * all persons of local age of consent or older who suffer non-traumatic cardiopulmonary arrest outside of the hospital in the study communities with defibrillation and/or delivery of chest compressions provided by emergency medical service (ems) providers dispatched to the scene and do not meet any of the exclusion criteria. exclusion criteria: common: * do not attempt resuscitation (dnar) orders * blunt, penetrating, or burn-related injury * patients with exsanguinations * known prisoners * known pregnancy * non-roc ems agency/provider for analyzing late versus early * ems-witnessed arrests * non-ems rhythm analysis (aed placed by police or lay responder is an exclusion but cpr by lay or other non-ems responders is not) for itd: * tracheostomy present * cpr performed with the mechanical compression "autopulse" device.

Keywords: cardiac arrest cardiopulmonary resuscitation
the cardio-sarcopenia study

Conditions: Cardiac Ageing; Physical Activity; Older Adults; Sarcopenia

Summary: the use of surrogate markers such as body mass index (bmi) as a target outcome of physical activity may not be appropriate in older adults who are at risk of muscle sarcopenia. in the presence of sarcopenia, reductions in body weight may lead to lower bmi values. we have previously found deleterious changes in cardiac structure and function among sarcopenic older adults, raising a possible biological syndrome of 'cardio-sarcopenia'. in this study, we will investigate the impact of physical activity on temporal changes in cardiac and skeletal muscle , and bmi, over six- to twelve month period, on older adults with this syndrome. by targeting the cardio-sarcopenic phenotype as a modifiable risk factor that may be altered by physical activity, the results will provide new knowledge into retarding deleterious consequences of cardiovascular ageing. this new target challenges the paradigm of using bmi as an anthropometric marker in health prevention. if proven, this will dramatically change primary prevention targets among older adults, justifying the use of cardio-sarcopenia as a rational anthropometric target.

this study builds upon our group's work where we characterized cardiovascular and skeletal muscle structure and function of community-based older adults. in this proposal, we will identify n=100 participants with cardio-sarcopenia phenotype. comparing between participants with baseline low versus high levels of physical activity, we will investigate temporal changes in their cardiovascular, skeletal muscle, biomarkers and bmi data, over a six- to twelve month period. physical activity will include subjective self-reported physical activities and objective measures of aerobic capacity. their physical activity levels will be verified bi-monthly via physical activity and cardiac health application that measures these markers. pertinent fluctuations in diet, lifestyle, risk factors and biomarkers will also be recorded.

Eligibility criteria:
inclusion criteria: * \>=21 years of age exclusion criteria: * unable to provide written informed consent to participate in the study.

Keywords: aging cardiovascular skeletal muscle sarcopenia prevention digital technology
mitochondrial function and metabolomic profile in alzheimer's disease and related dementias

Conditions: Alzheimer Disease

Summary: this project aims to study on one hand the early mitochondrial alterations, common or specific, occurring in peripheral cells of patients with alzheimer's disease or related dementia and, on the other hand, identify the metabolomic biomarkers that may be at the origin of mitochondrial disturbances associated with the disease. this will be the first study combining functional analyses of mitochondria and exploratory metabolomic assessments in the same cohort at early stages of the disease.

study will be proposed to the patient of the nice memory center who had a lumbar puncture and who agreed on the storage of a sample of their cerebrospinal fluid. two groups of patients will be compared: the alzheimer"s disease patient with positive amyloid on the cerebrospinal fluid and the non alzheimer patient with negative amyloid on the cerebrospinal fluid. blood samples will be collected at inclusion and one year to obtain the mitochondrial metabolomic signature

Eligibility criteria:
inclusion criteria: * neurocognitive disorder with spontaneous complaint or reported for at least 6 months * diagnostic process according to current haute autorité de santé (has) recommendations. * cerebrospinal fluid biomarker dosage done within the study center and agreement to bio-collection of residual cerebrospinal fluid * patient having agreed to sign the informed consent * patient affiliated or beneficiary of a social security scheme for alzheimer group : diagnosis of alzheimer's disease according to nia-aa 2024 criteria (presence of a pathogenic amyloid process in the cerebrospinal fluid) for non alzheimer group : diagnosis of mild or major neurocognitive disorder according to manuel diagnostique et statistique des troubles mentaux edition 5 (dsm-v) criteria, not linked to alzheimer's disease (absence of pathogenic amyloid process in the cerebrospinal fluid) exclusion criteria: - vulnerable people

Keywords: alzheimer mitochondrial function metabolomic
the impact of intravesical gemcitabine and 1/3 dose bacillus calmette-guerin on the quality of life in superficial bladder cancer

Conditions: Bladder Cancer

Summary: to our knowledge, there are no comparative studies on bacillus calmette-guerin (bcg) and intravesical chemotherapy addressing quality of life (qol) issues. the aim of this study was to prospectively evaluate and compare the qol of intermediate-risk non-muscle-invasive (nmibc) patients treated with bcg or gemcitabine.

intravesical bacillus calmette-guérin (bcg) is considered the most effective agent for non-muscle-invasive bladder cancer (nmibc), representing the first-line option in the management of carcinoma in situ (cis) and high-risk disease. in intermediate-risk nmibc, however, both bcg and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of bcg has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. according to current evidence, bcg is considered less tolerable than intravesical chemotherapy such as mitomycin-c or doxorubicin, based on reported side effects. among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in nmibc patients, including those at high-risk of disease recurrence, even if its role on the management of nmibc has not been well-defined yet. to our knowledge, there are no comparative studies on bcg and intravesical chemotherapy addressing quality of life (qol) issues. the aim of this study was to prospectively evaluate and compare the qol of intermediate-risk nmibc patients treated with bcg or gemcitabine.

Eligibility criteria:
inclusion criteria: * patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely ta-1, g1-2, multifocal or unique and recurrent, \>3 cm in diameter) * who performance status ≤2 * age ≤85years * bcg naive * patients not treated with intravesical chemotherapy in the last 3 months. exclusion criteria: * presence of t1g3 or cis * preoperative urinary cytology positive for high-grade atypia * inadequate bone marrow reserve (white blood cells \<3 x 109/l, platelets \<100 x 109/l) * history of genito-urinary tuberculosis * presence of uncontrolled urinary infections.

Keywords: non muscle invasive bladder cancer
continuous versus single-shot spinal anesthesia for orthopedic surgery

Conditions: Post Operative Pain

Summary: a study was conducted to compare the effectiveness of continuous spinal anesthesia (csa), single-shot spinal anesthesia (sssa), and general anesthesia (ga) in patients over 60 years of age undergoing elective surgical repair of a fractured neck of femur. one hundred and five patients were randomly assigned to one of the three groups. the sssa group received a single intrathecal injection of isobaric bupivacaine 0.5%, while the csa group received multiple injections of the same anesthetic through a catheter placed in the subarachnoid space. the ga group received isoflurane anesthesia. intraoperatively, blood pressure was monitored to assess the frequency of hypotension and the required dose of ephedrine. additionally, the total dose of bupivacaine administered and the frequency of intraoperative fentanyl were recorded. postoperatively, the duration of postoperative analgesia, pain scores, and need for additional pain medication were evaluated.


Eligibility criteria:
inclusion criteria: * patients of american society of anesthesiologists (asa) grade ≤iii; * patients were assigned for elective surgical intervention for fixation of neck femur; * patients were free of exclusion criteria. exclusion criteria: * patients of american society of anesthesiologists (asa) grade \>iii; * patients who had uncontrolled hypertension and/or diabetes mellitus; * patients who had uncompensated cardiac, renal, or hepatic diseases; * patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs; * patients who refused to sign the informed consent were excluded from the study.
interactive stepping exercise on balance and cognitive function

Conditions: Parkinson's Disease

Summary: the objective of this study is to investigate the effects of interactive stepping exercise on balance and cognitive function in individuals with pd.


Eligibility criteria:
inclusion criteria: * idiopathic pd * hoehn \& yahr stage between 1 to 3 * age between 50 to 85 * stable pharmacologic treatment for the last 2 weeks * ability to walk 10 meters unassisted or with assistive devices exclusion criteria: * other neurological disorders diagnosis than pd * receiving any neurological surgeries * any musculoskeletal disorder or cardiopulmonary disease that may influence participation in the study * the mini-mental state examination (mmse) \< 24 scores * participated in other exercise intervention of study in the past 3 months * colorblindness or color vision deficiency

Keywords: interactive stepping exercise square stepping exercise parkinson's disease balance ability cognitive function
concomitant or sequential phlebectomy after endovenous laser therapy for varicose veins

Conditions: Varicose Veins; Endovenous Laser Ablation; Phlebectomies

Summary: varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. when treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. this trial aims to see if it is better to remove these veins at the time of the first laser procedure or better to leave them and only remove them when asked.

endovenous laser therapy (evlt) for varicose veins is associated with high initial occlusion rates, minimal complications and low recurrence rates at 5 years. randomized trials and meta-analyses have confirmed the efficacy of evlt in comparison with surgery and other endovenous techniques. there is also evidence that it may be associated with early quality of life (qol) benefits compared with surgery. the general efficacy of evlt has therefore been demonstrated and current research focuses on refinement of the procedure. a fundamental question concerns the management of residual varicosities following truncal laser ablation. one approach is to leave these varicosities to regress untouched, minimizing the procedure time and surgical trauma6. this approach, however, is associated with a significant number of secondary and tertiary interventions (sclerotherapy and/or ambulatory phlebectomy). another option is to combine in a single procedure ambulatory phlebectomy with initial truncal laser ablation (evltap). the aim of this randomized controlled trial was to assess the advantages of performing ambulatory phlebectomy as a concomitant procedure to truncal laser ablation.

Eligibility criteria:
inclusion criteria: * primary, symptomatic, unilateral varicose great saphenous veins (gsv), with isolated saphenofemoral junction (sfj) incompetence and gsv reflux on venous duplex imaging, * perigenicular vein diameter exceeding 4 mm, * acceptance by the patient of a local anaesthetic procedure. exclusion criteria: * saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging * did not give consent to trial participation.

Keywords: varicose veins
a trial to compare the duration of analgesic efficacy and safety of naproxen sodium tablets and ibuprofen tablets in postsurgical dental pain

Conditions: Pain, Postoperative

Summary: to compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain. to compare the overall analgesic effect (spid 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo. to compare the overall relief from pain (totpar 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.


Eligibility criteria:
inclusion criteria: * healthy, ambulatory, male or female volunteers 16-40 years of age; * body mass index 18.0 to 30.0 kg/m\^2 inclusive; * scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. up to two maxillary third molars may be removed regardless of impaction level. supernumerary teeth present may also be removed at the discretion of the oral surgeon; * mandibular molars must demonstrate modified demirjian root classification stage d, e, f, g or h; exclusion criteria: * history of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (nsaids), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products; * evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years; * relevant concomitant disease such as asthma (exercise induced asthma is permitted)

Keywords: postsurgical pain
cardiac output monitoring managing intravenous therapy (commit) to treat emergency department severe sepsis

Conditions: Sepsis

Summary: the primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the serial organ failure assessment score ≥ 1 over the first 72 hours) in sepsis patients presenting to the emergency department without evidence of shock.


Eligibility criteria:
inclusion criteria: 1. adult patients \> 18 years with old suspected or confirmed infection 2. at least two of the following four criteria (sirs): 1. temperature \> 38 or \< 36o c 2. heart rate \> 90 bpm 3. respiratory rate \> 20 bpm or paco2\< 32 mmhg 4. white blood cell count \>12,000 or \ 10% bandemia 3. lactate ≥2.0 and ≤4.0 mmol/l 4. enrollment within 6 hours of ed presentation within 2.5 hours of meeting eligibility criteria exclusion criteria: 1. age \< 18 years 2. on vasopressor therapy 3. systolic blood pressure \< 90 mmhg 4. received more than 3-liter crystalloid fluid prior to randomization 5. patient presenting with pulmonary edema 6. patient presenting with acute coronary syndrome 7. patient presenting with new onset cardiac arrhythmia 8. patient presenting with trauma, including burns 9. patient requires immediate surgery 10. patient presenting with stroke 11. patient with end stage renal disease on renal replacement therapy 12. patient with known pregnancy 13. patient being treated with immunosuppressive therapy for organ transplant
the use of the master caution system (mcs) for continuous monitoring and detection of dysrhythmias and ischemic events

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to evaluate the effectiveness and usability of the master caution system for 12 leads continuous monitoring of ecg signal in the iccu. the purpose of the study is to evaluate the effectiveness and usability of using master caution 12 leads garment for stress test. the purpose of the study is to reassess the adequate size of the master caution garment.


Eligibility criteria:
inclusion criteria: * age\>18 years. * diagnosed or have evidence of acs, or referred for stress imaging due to suspected ischemia with stt changes. * needs continuous/routine ecg monitoring. * ability to give informed consent. * cooperative person exclusion criteria: * patients with known allergy to silver. * patients with dermal disease or recent trauma to the chest wall. * pregnant or lactating woman. * patients with chest deformity precluding placement of the garment. * patients suffering from tremor. * patients participating in another ongoing trial.
rhgm-csf as adjuvant immunotherapy in treating stage iii colon cancer

Conditions: Colon Cancer

Summary: this study is to investigate the efficacy and safety of rhgm-csf as adjuvant immunotherapy for patients with resectable stage iii colon cancers.

this study is to investigate the efficacy and safety of rhgm-csf as adjuvant immunotherapy for patients with resectable stage iii colon cancers. patients were randomly assigned to rhgm-csf group or placebo group and treated with rhgm-csf or placebo perioperation and during the adjuvant chemotherapy. the purpose of the study is to evaluate the antitumor immune effect of rhgm-csf before surgery and adjuvant chemotherapy through dfs of 5 years and to observe the safety during the treatment in order to provide evidence for improvement in treating resectable colon cancer patients.

Eligibility criteria:
inclusion criteria: 1. diagnosed as resectable stage iii colon cancer 2. 18-70 years old 3. ecog performance status ≤2 4. unexposed to rhgm-csf in 6 months 5. signed an informed consent document exclusion criteria: 1. secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years) 2. complete intestinal obstruction 3. events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( nyha functional class of iii or iv ), stroke and any myocardial dysfunction in a transient ischaemic attack 4. abnormal liver and kidney function (serum creatinine \> 1.5 x uln, total bilirubin \> 1.5 x uln, transaminase \> 3 x uln ), abnormal pulmonary function (fev1\<60% or diffusing capacity of the lung for carbon monoxide \< 55% ) 5. bone marrow dysfunction ( hb\<9.0 g/dl、anc\<1.5 x 109/l、plt\<100 x 109/l ) 6. itp or immunodeficiency 7. uncontrolled infection, including hbv, hcv, hiv infection 8. female patients who has been pregnant or planning to, and those during lactation 9. known allergic to e.coli agents or rhgm-csf or any severe allergic history to other drugs 10. other cases that the researcher found ineligible

Keywords: stage iii colon cancer rhgm-csf immunotherapy surgery adjuvant chemotherapy